Evidence map›Paper›PMID 31907006›Full record

ArticleTrials2020

Vitamin D supplementation compared to placebo in people with First Episode psychosis - Neuroprotection Design (DFEND): a protocol for a randomised, double-blind, placebo-controlled, parallel-group trial.

Fiona Gaughran, Dominic Stringer, Michael Berk, Shubulade Smith, David Taylor, Eromona Whiskey, Sabine Landau, Robin Murray, Philip McGuire, Poonam Gardner-Sood and 13 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Vitamin D and schizophrenia: 20 years on.Molecular psychiatry · 2021
    Pooled it
  2. Trial
  3. Article
  4. Vitamin D and Vitamin BDiseases (Basel, Switzerland) · 2026
    Review
  5. Review
  6. Review
  7. Article
  8. Anti-Inflammatory Diets and Schizophrenia.Clinical nutrition research · 2020
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors at 8 institutions in 3 countries.

Fiona GaughranDepartment of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK. fiona.p.gaughran@kcl.ac.uk.
Dominic StringerDepartment of Biostatistics and Health Informatics, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
Michael BerkDeakin University and Barwon Health, Ryrie Street, Geelong, Victoria, 3220, Australia.
Shubulade SmithDepartment of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
David TaylorSouth London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK.
Eromona WhiskeyDepartment of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
Sabine LandauDepartment of Biostatistics and Health Informatics, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
Robin MurrayDepartment of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
Philip McGuireDepartment of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
Poonam Gardner-SoodDepartment of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
Gabriella WojewodkaDepartment of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
Simone CiufoliniDepartment of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
Harriet JordanDepartment of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
Jessie ClarkeDepartment of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
Lauren AllenDepartment of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
Amir KrivoyDepartment of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
Brendon StubbsDepartment of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
Philippa LoweCarer Expert and Chair of Trustees, Rethink Mental Illness, 89 Albert Embankment, London, SE1 7TP, UK.
Maurice Arbuthnott, London, UK.
Shanaya RathodClinical Trials Facility, Research Department, Tom Rudd Unit, Moorgreen Hospital, Southampton, SO3 03J, UK.
Andrew BoardmanCheshire & Wirral Partnership NHS Trust, Churton House, Countess of Chester Health Park, Chester, CH2 1BQ, UK.
Mudasir FirdosiSouth West London and St George's Mental Health NHS Trust, Queen Mary's Hospital, Roehampton Lane, London, SW15 5PN, UK.
John J McGrathQueensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, QLD, 4076, Australia.
King's College London · GBSouth London and Maudsley NHS Foundation Trust · GBAarhus University · DKBarwon Health · AUCheshire West and Chester · GBMoorgreen Hospital · GBRethink Mental Illness · GBSouth West London and St George's Mental Health NHS Trust · GB

Funding

Stanley Medical Research Institute 13T-006
6 · The paper itself

Abstract

backgroundPeople experiencing their first episode of psychosis are often deficient in vitamin D. Observational studies have reported an association between low vitamin D concentrations and poorer subsequent health outcomes in psychosis. A vitamin D deficiency in neonates and children has been linked to a later increased risk of schizophrenia and psychotic-like experiences. This trial aims to examine the effect of high-dose vitamin D supplementation on outcomes in early psychosis. We hypothesise that vitamin D supplementation will be associated with better mental health outcomes. METHODS/

designThe DFEND study is a multicentre double-blind placebo-controlled parallel-group trial of vitamin D supplementation in people with early psychosis. Patients with an ICD-10 diagnosis of functional psychosis will be randomised in a 1:1 ratio to receive either 120,000 IU/month of vitamin D (cholecalciferol) or a matched placebo for 6 months. The primary outcome is the total Positive and Negative Syndrome Scale (PANSS) score at the 6-month follow-up for all patients. Secondary outcomes include assessment of mood (Calgary Depression Scale), general function (Global Assessment of Functioning), cardiovascular risk (body mass index, waist circumference, C-reactive protein, cholesterol and HbA1c) and vitamin D levels at the 6-month follow-up. Additionally, 3- and 6-month total PANSS scores will be analysed for those with inadequate vitamin D levels at the baseline. DISCUSSION: The DFEND study is the first trial to examine whether vitamin D supplementation in early psychosis is associated with better mental health outcomes. The findings of this study may help to resolve the clinical equipoise regarding the benefits and cost-effectiveness of routine vitamin D supplementation in people with psychosis.

trial registrationISRCTN, ISRCTN12424842. Registered on 25 February 2015.

Indexed as

Dietary SupplementsAdultClinical Trials, Phase II as TopicDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMental HealthMiddle AgedNeuroprotectionPlacebosPsychiatric Status Rating ScalesPsychotic DisordersRandomized Controlled Trials as TopicTreatment OutcomePlacebosVitamin D25OHDFirst episodeMental healthPositive and Negative Syndrome ScalePsychosisRandomised controlled trialVitamin D

Identifiers

PMID31907006
PMCPMC6945550
OpenAlexW2994983989

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.